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Validated quantitative P-31 NMR spectroscopy for positional isomeric impurity determination in L-alpha-glycerylphosphorylcholine (L-alpha-GPC)

文献类型：期刊论文

作者Sun, Ling2; Fan, Yujuan2,3; Wang, Qiaoqiao2; Xiang, Lili2; Han, Haiyun2; Chen, Dongying1,2,3
刊名JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
出版日期2022-11-30
卷号221页码:5
ISSN号0731-7085
关键词P-31 NMR spectroscopy Positional isomers Impurity L-alpha-glycerylphosphorylcholine (L-alpha-GPC) Method validation Quality control
DOI10.1016/j.jpba.2022.115067
通讯作者Chen, Dongying(dychen@simm.ac.cn)
英文摘要In this study a quantitative P-31 nuclear magnetic resonance (P-31 NMR) spectroscopy method was described to determine positional isomeric impurity beta-GPC in commercial products of L-alpha-GPC. The samples were dissolved in D2O and trimethyl phosphate (TMP) was selected as an internal calibrant. The measurements were performed on a Bruker 500 MHz spectrometer and the spectra were recorded under optimized process conditions. A good linear relationship was constructed for beta-GPC in the range of 62.7-528.0 mu g.mL(-1), i.e. 0.03-0.25 % (w/w %, in relative to L-alpha-GPC) with a correlative coefficient of 0.9996. The limit of quantification (LOQ) and limit of detection (LOD) were 62.7 mu g.mL(-1) and 20.9 mu g.mL(-1) with signal to noise of 3 and 10, respectively. The spiked recoveries were in the range of 98.17-99.78 % with the relative standard deviation (RSD %) less than 1.0 %. Therefore, it could be supposed that the P-31 NMR was a promising alternative method for sensitive determination of beta-GPC for strict quality control of L-alpha-GPC.
WOS关键词SIMULTANEOUS QUANTIFICATION ; H-1 ; MULTICENTER ; DEMENTIA ; H-1-NMR
WOS研究方向Chemistry ; Pharmacology & Pharmacy
语种英语
出版者ELSEVIER
WOS记录号WOS:000888845600011
源URL[http://119.78.100.183/handle/2S10ELR8/304575]  
专题中国科学院上海药物研究所
通讯作者Chen, Dongying
作者单位1.Univ Chinese Acad Sci, Beijing 100049, Peoples R China
2.Chinese Acad Sci, Shanghai Inst Mat Med, Lab Pharmaceut Anal, Shanghai 201203, Peoples R China
3.Nanjing Univ Chinese Med, Sch Chinese Mat Med, Nanjing 210023, Peoples R China
推荐引用方式
GB/T 7714		 Sun, Ling,Fan, Yujuan,Wang, Qiaoqiao,et al. Validated quantitative P-31 NMR spectroscopy for positional isomeric impurity determination in L-alpha-glycerylphosphorylcholine (L-alpha-GPC)[J]. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS,2022,221:5.
APA Sun, Ling,Fan, Yujuan,Wang, Qiaoqiao,Xiang, Lili,Han, Haiyun,&Chen, Dongying.(2022).Validated quantitative P-31 NMR spectroscopy for positional isomeric impurity determination in L-alpha-glycerylphosphorylcholine (L-alpha-GPC).JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS,221,5.
MLA Sun, Ling,et al."Validated quantitative P-31 NMR spectroscopy for positional isomeric impurity determination in L-alpha-glycerylphosphorylcholine (L-alpha-GPC)".JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS 221(2022):5.

入库方式： OAI收割

来源：上海药物研究所

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